Ventazol

Package leaflet: Information for the patient

Ventazol, 20 mg, hard enteric-coated capsules
Omeprazolum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:
What Ventazol is and what it is used for
What you need to know before taking Ventazol
How to take Ventazol
Possible side effects
How to store Ventazol
Contents of the pack and other information

1. What Ventazol is and what it is used for

Ventazol contains an active substance called omeprazole. It belongs to a group of medicines known as
"proton pump inhibitors". These medicines reduce the amount of acid produced in the stomach.
Ventazol is used to treat the following conditions:
Adults:

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid passes back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers of the upper intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers caused by infection with a bacterium called Helicobacter pylori. Your doctor may prescribe antibiotics to eliminate the infection and help heal the ulcers.
• Ulcers caused by taking medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Ventazol may be used to prevent ulcers from developing during NSAID treatment.
• Excess stomach acid caused by changes in the pancreas (Zollinger-Ellison syndrome).

Children and adolescents:
Children above 1 year of age with body weight ≥ 10 kg

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid passes back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.

In children, symptoms of this condition may also include regurgitation of stomach contents into the mouth (acid reflux), nausea (vomiting), and poor weight gain.
Children above 4 years of age and adolescents:

• Ulcers caused by infection with a bacterium called Helicobacter pylori. Your doctor may prescribe antibiotics to eliminate the infection and help heal the ulcers.

2. Information before using Ventazol

When not to use Ventazol

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic (hypersensitive) to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If the patient is currently taking nelfinavir (a medicine used to treat HIV infection).

If any of the above situations apply, Ventazol must not be used. The patient should
contact a doctor. If in doubt, contact a doctor or pharmacist before taking Ventazol.
Warnings and precautions
Before starting treatment with Ventazol, discuss it with a doctor or pharmacist.
Severe skin reactions have been reported during treatment with omeprazole, including
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If the patient develops any of these symptoms related to severe skin reactions listed in section 4, treatment with omeprazole must be stopped immediately and medical help should be sought without delay.
Treatment with Ventazol may mask symptoms of other diseases. Therefore, the patient should inform the doctor immediately if any of the following symptoms occur before or during treatment with Ventazol:

• Significant, unintentional weight loss and difficulty swallowing.
• Abdominal pain or indigestion symptoms.
• Vomiting or vomiting blood.
• Black, tarry stools.
• Severe or persistent diarrhoea, as omeprazole may slightly increase the risk of bacterial diarrhoea.
• Severe liver disease.
• If the patient has ever had a skin reaction due to taking a medicine similar to Ventazol that reduces gastric acid secretion.
• A specific blood test (chromogranin A level) is planned.

This medicine may affect vitamin B₁₂ absorption, especially if long-term use is required. Contact a doctor if any of the following symptoms occur, which may indicate reduced vitamin B₁₂ levels:

• Extreme tiredness or lack of energy
• Tingling or prickling sensations
• Pain or redness of the tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Renal inflammation may occur during treatment with omeprazole. Signs and symptoms may include reduced urine volume or blood in urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Such symptoms should be reported to the treating physician.
If the patient takes Ventazol for a long time (longer than 1 year), the doctor will likely perform regular health check-ups. During follow-up visits, all new or unusual symptoms should be reported to the doctor.
Long-term use of proton pump inhibitors such as Ventazol, particularly for over one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if osteoporosis has been diagnosed or if corticosteroid medicines (which may increase the risk of osteoporosis) are being taken.
If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Ventazol may be necessary. Also report any other adverse reactions such as joint pain.
Children
Some children with chronic diseases may require long-term treatment, but such treatment is not recommended. Do not use this medicine in children under 1 year of age weighing < 10 kg.
Ventazol with other medicines
Tell the doctor about all medicines currently taken, recently taken, or planned for use. This includes medicines obtained without a prescription. This is important because Ventazol may alter the effect of other medicines, or the effect of Ventazol may be altered when other medicines are taken.
Do not take Ventazol if taking a medicine containing nelfinavir (a medicine used to treat HIV infection).
Inform the doctor or pharmacist if any of the following medicines are being taken:

• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections)
• Digoxin (a medicine used to treat heart conditions)
• Diazepam (a medicine used to treat anxiety, epilepsy, or to relax muscles)
• Phenytoin (a medicine used to treat epilepsy). If taking phenytoin, the doctor may order additional blood tests at the beginning and after completion of treatment with Ventazol
• Anticoagulants such as warfarin or other vitamin K antagonists. The doctor may recommend additional monitoring at the start and after completion of treatment with Ventazol
• Rifampicin (a medicine used to treat tuberculosis)
• Atazanavir (a medicine used to treat HIV infection)
• Tacrolimus (a medicine used to prevent organ transplant rejection)
• St John's wort (Hypericum perforatum) (a herbal remedy used to treat mild depression)
• Cilostazol (a medicine used to treat intermittent claudication)
• Saquinavir (a medicine used to treat HIV infection)
• Clopidogrel (a medicine used to prevent blood clots)
• Erlotinib (used in cancer treatment)
• Methotrexate (a medicine used in high doses in chemotherapy for cancer treatment) – if methotrexate is used in high doses, the doctor may temporarily discontinue Ventazol.

If the doctor prescribes antibiotics, amoxicillin and clarithromycin, to be taken together with Ventazol for the treatment of ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about any other medicines being taken.
Ventazol with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Omeprazole passes into human milk, but is unlikely to affect the infant when used at therapeutic doses.
The doctor will decide whether the patient can take Ventazol while breastfeeding.
Driving and using machines
Ventazol is unlikely to affect the ability to drive or operate machinery. However, if adverse effects such as dizziness or visual disturbances occur (see section 4), do not drive, use tools, or operate machinery.
Ventazol contains sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Ventazol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Ventazol

Ventazol should be taken as directed by the doctor or pharmacist. If you have any doubts,
you should contact your doctor or pharmacist.
The dosage and duration of treatment are determined by the doctor and depend on the patient's condition and age.

Recommended doses:
Adults:
Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of acidic stomach contents into the oesophagus:

• If the doctor has determined that the gastrointestinal tract (oesophagus) is slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. In patients who have not healed during this time, the doctor may recommend a dose of 40 mg for a further 8 weeks.
• The usual dose in patients with healed oesophagus is 10 mg once daily.
• If the gastrointestinal tract is not damaged, the usual dose is 10 mg once daily.

Treatment of peptic ulcers in the upper intestine (duodenal ulcer disease):

• The usual dose is 20 mg once daily for 2 weeks. In patients who have not healed during this time, the doctor may recommend continuing 20 mg for a further 2 weeks.
• In patients who have not fully healed, the doctor may recommend a dose of 40 mg for 4 weeks.

Treatment of gastric ulcers (gastric ulcer disease):

• The usual dose is 20 mg once daily for 4 weeks. In patients who have not healed during this time, the doctor may recommend continuing 20 mg for a further 4 weeks.
• In patients who have not fully healed, the doctor may recommend a dose of 40 mg for 8 weeks.

Prevention of recurrence of gastric and duodenal ulcers:

• The usual dose is 10 mg or 20 mg once daily. The doctor may also recommend a higher dose of 40 mg once daily.

Treatment of ulcers in the stomach and duodenum caused by use of non-steroidal anti-inflammatory drugs (NSAIDs):

• The usual dose is 20 mg once daily for 4–8 weeks.

Prevention of gastric and duodenal ulcers during use of non-steroidal anti-inflammatory drugs:

• The usual dose is 20 mg once daily.

Treatment and prevention of ulcers associated with Helicobacter pylori infection:

• The usual dose is 20 mg twice daily for one week.
• The doctor will also recommend treatment with two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by pancreatic disorders (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will determine the dose and duration of treatment depending on symptoms.

Use in children and adolescents:
Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of acidic stomach contents into the oesophagus:

• Ventazol may be used in children over 1 year of age and weighing more than 10 kg. The doctor will recommend a dose appropriate to body weight.

Treatment and prevention of ulcers associated with Helicobacter pylori infection:

• Ventazol may be used in children aged over 4 years. The doctor will recommend a dose appropriate to body weight.
• The doctor will also recommend treatment with two antibiotics: amoxicillin and clarithromycin.

How to take Ventazol

• It is recommended to take Ventazol in the morning.
• Ventazol may be taken on an empty stomach or with food.
• The capsule should be swallowed whole with water. Do not chew or crush the capsules, as the coating protecting the drug pellets from gastric juice may be damaged. It is important not to damage the pellets.

What to do if adults or children have difficulty swallowing

• If you have difficulty swallowing the capsules:
  • Open the capsule, swallow the contents with half a glass of water, or mix the capsule contents with a small amount of yoghurt or acidic fruit juice (e.g. apple, orange, or pineapple juice) or apple puree.
  • Always stir the mixture before drinking (the mixture will not be clear). The mixture should be taken immediately or within 30 minutes of preparation.
  • To ensure the entire dose is taken, fill the glass halfway with water, stir and drink the liquid. Undissolved particles contain the active drug; do not chew or crush them.

Taking more Ventazol than recommended
If you take more Ventazol than recommended, contact your doctor or pharmacist immediately.

Missed dose of Ventazol
Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for a missed one.

Stopping Ventazol treatment
Do not stop taking Ventazol without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will get them.
If any of the following serious adverse reactions occur, which are rare (may affect up to 1 in 1,000 patients)
or very rare (may affect up to 1 in 10,000 patients), stop taking Ventazol and contact your doctor immediately:

• Wheezing, swelling of lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Reddening of the skin with blistering or peeling. Blisters and bleeding from the mouth, eyes, nose and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine and feeling tired, which may be symptoms of liver disease (rare).

Other adverse reactions:
Common adverse reactions (may affect up to 1 in 10 patients):

• Headache.
• Gastrointestinal symptoms: diarrhoea, abdominal pain, constipation, bloating with passing wind.
• Nausea or vomiting.
• Mild gastric polyps.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, prickling, tingling and numbness, drowsiness.
• Sensation of spinning (vertigo).
• Changes in blood tests assessing liver function.
• Rash, nodular rash (urticaria), itchy skin.
• General malaise and weakness.

Rare adverse reactions (may affect up to 1 in 1,000 patients):

• Blood disorders, such as reduced white blood cell or platelet counts. These may cause weakness, bruising and increased susceptibility to infections.
• Allergic reactions, sometimes very severe, including swelling of lips, tongue, throat, fever, and breathing difficulties.
• Low blood sodium levels. These may cause weakness, nausea (vomiting) and cramps.
• Feeling of restlessness, disorientation or depression.
• Changes in taste perception.
• Eye disorders, such as blurred vision.
• Sudden shortness of breath, breathing difficulties (bronchospasm).
• Dryness of the oral mucosa.
• Inflammation in the mouth.
• Fungal infection known as "thrush", which may affect the intestines.
• Hair loss.
• Photosensitivity (rash after sun exposure).
• Joint or muscle pain.
• Severe kidney disease (interstitial nephritis).
• Increased sweating.

Very rare adverse reactions (may affect less than 1 in 10,000 patients):

• Decreased blood cell counts, including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver disease, including liver failure and encephalitis.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in males.

Frequency not known (frequency cannot be estimated from available data):

• Inflammation of the intestines (leading to diarrhoea).
• Taking Ventazol for longer than three months may lead to reduced magnesium levels in the blood. Magnesium deficiency may result in symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash which may be accompanied by joint pain.

Very rarely, Ventazol may damage white blood cells and cause immunodeficiency.
You should consult your doctor as soon as possible if you develop an infection with fever accompanied by severe
worsening of general condition or fever with signs of local infection such as pain in the neck, throat or mouth,
difficulty urinating, because blood tests are needed to rule out low white blood cell counts (agranulocytosis).
It is important to inform your doctor about all medicines you are taking at the time.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ventazol

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack
following: "EXP". The expiry date refers to the last day of the specified month. HDPE bottle: The medicine should be used within 105 days after first opening.
Store below 25°C.
Keep in the original packaging and keep the bottle tightly closed to protect from moisture. After use, tighten the cap securely.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ventazol contains

• The active substance is omeprazole. One capsule contains 20 mg of omeprazole.
• Other components are:
  • Capsule contents: sucrose, granules (sucrose and corn starch), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 6 cP, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide (E 171), copolymer of methacrylic acid and ethyl acrylate (1:1).
  • Capsule shell: gelatin. The 20 mg capsules contain the colouring quinoline yellow (E 104) and titanium dioxide (E 171).

What Ventazol looks like and contents of the pack
Ventazol 20 mg: an opaque, yellow capsule containing spherical pellets ranging in colour from whitish to creamy-white.
Ventazol 20 mg is available in the following pack sizes:

• Blister pack – the pack contains 7, 14, 15, 28, 30, 50, 56, 60, or 90 capsules.
• HDPE bottle – the pack contains 7, 14, 15, 28, 30, 50, 56, 60, or 90 capsules.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Manufacturers
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, N°7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
Sandoz A/S
Edvard Thomsens Vej 14
2300 København S
Denmark
NOVARTIS PHARMA GmbH
Roonstrasse 25
90429 Nürnberg
Germany
NOVARTIS FARMACÉUTICA S.A.
Gran Vía de les Corts Catalanes 764
08013 Barcelona
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Omeprazol Sandoz capsule 20 mg, gastro-resistant capsule, hard
Austria Omoquis 20 mg magensaftresistente Hartkapseln
Belgium Omeprazol AB 20mg, capsules gastro-résistantes, hard
Denmark Omeprazol Sandoz
Iceland Omeprazol Sandoz 20 mg magasýruþolin hörð hylki
Norway Omeprazol Sandoz 20 mg enterokapsel, hard
Poland Ventazol
Portugal Omoquis
Sweden Omeprazol Sandoz hårda enterokapslar
United Kingdom Omeprazole 20 mg gastro-resistant capsules